Trial · NCT06346392
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) in all randomized participants | From date of first dose/randomisation until disease progression or death in the absence of progression (approximately 3 years). | The analysis will include all randomized participants. All events will be included, regardless of whether the participant withdraws from therapy or receives another anticancer therapy. |
| Primary | Overall Survival (OS) for 3L+ participants | From date of first dose/randomisation until the date of death due to any cause (approximately 3 years). | The analysis will include all randomized participants who had at least 2 prior lines of systemic therapy. All deaths will be included, regardless of whether the participant withdraws from therapy or receives another anticancer therapy. |
| Secondary | OS in all randomized participants | From date of first dose/randomisation until the date of death due to any cause (approximately 3 years). | The analysis will include all randomized participants. All deaths will be included, regardless of whether the participant withdraws from therapy or receives another anticancer therapy. |
| Secondary | PFS for 3L+ participants | From date of first dose/randomisation until disease progression or death in the absence of progression (approximately 3 years). | The analysis will include all randomized participants who had at least 2 prior lines of systemic therapy. All events will be included, regardless of whether the participant withdraws from therapy or receives another anticancer therapy. |
| Secondary | Objective Response Rate (ORR) in all randomized participants | From date of first dose of AZD0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 3 years). | ORR is defined as the proportion of participants with at least one visit response of confirmed CR or confirmed PR, as determined by BICR per RECIST 1.1. |
| Secondary | ORR for 3L+ participants | From date of first dose of AZD0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 3 years). | The analysis will include all randomized participants who had at least 2 prior lines of systemic therapy, with measurable disease at baseline |
| Secondary | Duration of Response (DoR) in all randomized participants | From the date of first documented confirmed response until date of documented progression (approximately 3 years). | The analysis will include all randomized participants with measurable disease at baseline who have a confirmed response. All events after achieving confirmed response will be included, regardless of whether the participant withdraws from therapy, receives another anticancer therapy or clinically progresses prior to RECIST 1.1. |
| Secondary | Serum concentrations of AZD0901, total antibody and MMAE | From date of first dose of AZD0901 up until 30 days post AZD0901 discontinuation. | To characterise the PK of AZD0901 in participants. |
| Secondary | Status of ADA to AZD0901 | From date of first dose of AZD0901 up until 30 days post AZD0901 discontinuation. | To determine the immunogenicity of AZD0901 in participants. |
| Secondary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]. Changes from baseline in vital signs, clinical laboratory results, and ECGs | From start through 30 days post treatment completion and follow up for 90 days. | To assess the safety and tolerability of AZD0901 as compared with Investigator's choice of therapy in all randomized participants who have received at least one dose of study intervention |
| Secondary | PK parameters (such as peak concentration, as data allow) of AZD0901, total antibody and MMAE | From date of first dose of AZD0901 up until 30 days post AZD0901 discontinuation. | To characterise the PK of AZD0901 in participants. |
| Secondary | PK parameters (such as trough concentration, as data allow) of AZD0901, total antibody and MMAE | From date of first dose of AZD0901 up until 30 days post AZD0901 discontinuation. | To characterise the PK of AZD0901 in participants. |
| Secondary | Prevalence and incidence of ADA to AZD0901 | From date of first dose of AZD0901 up until 30 days post AZD0901 discontinuation. | To determine the immunogenicity of AZD0901 in participants. |
| Secondary | Titer of ADA to AZD0901 | From date of first dose of AZD0901 up until 30 days post AZD0901 discontinuation. | To determine the immunogenicity of AZD0901 in participants. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT06346392/registered